The Regulatory Process for Imaging Agents and Devices

Matthew F. Covington, Sally W. Schwarz, John M. Hoffman

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

Abstract

This chapter will provide an overview of the process to obtain regulatory approval for molecular imaging agents (probes) and devices for clinical research use. Regulatory approval involves both the university and the US Food and Drug Administration (FDA). There is an infrastructure in place to assure compliance with all rules and regulations. As has been shown in the various chapters in this book, molecular imaging techniques allow for identification of important molecular pathways and biologic processes in both healthy and disease states. Molecular imaging techniques are used to individualize and personalize treatments based on a “molecular phenotype” of the disease at the time of diagnosis and throughout the course of therapy. Being knowledgeable regarding regulatory requirements will assist in obtaining appropriate molecular imaging approvals and detail the required reporting for the studies.

Original languageEnglish
Title of host publicationMolecular Imaging
Subtitle of host publicationPrinciples and Practice
PublisherElsevier
Pages1643-1661
Number of pages19
ISBN (Electronic)9780128163863
ISBN (Print)9780128163870
DOIs
StatePublished - Jan 1 2021

Keywords

  • Drug
  • Drug development process
  • Food and Drug Administration
  • Imaging
  • Molecular
  • Molecular imaging
  • Regulatory

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